Raltegravir side effects: what 16,416 FDA adverse event reports show

Raltegravir · Isentress · 1,084 reaction terms · 55,718 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Isentress

openFDA label

Who reports

16,416 reports · 83% serious · 1,634 with death outcome · 35% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Adult Patients: ISENTRESS and ISENTRESS HD are human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients ( 1 ). Pedia.

FDA label, Indications and Usage

What it is

ISENTRESS contains raltegravir potassium, a human immunodeficiency virus integrase strand transfer inhibitor.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Lab value / disease marker 3Not in label — unassessed 37

What the badges mean

Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,044 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Pulmonary valve sclerosis	10	6,298.0 1,380.0–28,742.1ROR 6,301.8 · χ² 9,469 / p <1e-300	348.7 EB05 202.4 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=10	no trial arm names this drug
Cloacal exstrophy	32	1,492.9 894.7–2,490.9ROR 1,495.8 · χ² 21,154 / p <1e-300	484.6 EB05 359.4 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=32 · 94% clinician	no trial arm names this drug
Ultrasound antenatal screen	50	1,431.4 954.8–2,145.7ROR 1,435.7 · χ² 32,787 / p <1e-300	533.0 EB05 420.1 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious n=50 · 100% clinician	no trial arm names this drug
Progressive external ophthalmoplegia	68	1,404.1 994.1–1,983.2ROR 1,410.0 · χ² 44,425 / p <1e-300	559.3 EB05 456.4 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious n=68 · ♀ 0% (drug 35%) · 93% clinician	no trial arm names this drug
Bladder agenesis	33	1,013.8 641.2–1,603.0ROR 1,015.9 · χ² 17,943 / p <1e-300	423.6 EB05 315.6 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious n=33 · 94% clinician	no trial arm names this drug
Gastrointestinal disorder congenital	32	552.2 364.5–836.4ROR 553.2 · χ² 11,859 / p <1e-300	312.4 EB05 231.7 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious n=32 · 94% clinician	no trial arm names this drug
Antiviral drug level below therapeutic	10	466.5 225.9–963.6ROR 466.8 · χ² 3,058 / p <1e-300	206.8 EB05 120.0 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious n=10	no trial arm names this drug
Caudal regression syndrome	41	449.1 314.5–641.2ROR 450.2 · χ² 13,184 / p <1e-300	287.0 EB05 220.5 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=41	no trial arm names this drug
Ectopic kidney	23	419.9 262.0–672.9ROR 420.5 · χ² 6,897 / p <1e-300	249.8 EB05 175.3 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=23 · ♀ 100% (drug 35%)	no trial arm names this drug
Aids dementia complex	15	410.7 229.4–735.5ROR 411.1 · χ² 4,319 / p <1e-300	222.5 EB05 143.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=15	no trial arm names this drug
Hemivertebra	38	365.4 254.7–524.1ROR 366.2 · χ² 10,423 / p <1e-300	248.1 EB05 188.7 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious n=38	no trial arm names this drug
Hiv associated nephropathy	11	355.3 182.0–693.6ROR 355.5 · χ² 2,761 / p <1e-300	187.6 EB05 111.8 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Csf hiv escape syndrome	30	349.9 233.6–524.2ROR 350.5 · χ² 7,897 / p <1e-300	233.4 EB05 171.4 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=30 · 100% clinician	no trial arm names this drug
Congenital ectopic bladder	10	340.4 169.3–684.4ROR 340.6 · χ² 2,404 / p <1e-300	177.8 EB05 103.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=10	no trial arm names this drug
Congenital genital malformation	31	302.7 204.6–447.9ROR 303.3 · χ² 7,274 / p <1e-300	212.4 EB05 156.7 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=31 · ♀ 100% (drug 35%) · 100% clinician	no trial arm names this drug
Hiv-associated neurocognitive disorder	21	293.9 182.8–472.5ROR 294.3 · χ² 4,736 / p <1e-300	196.2 EB05 135.4 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=21 · 90% clinician	no trial arm names this drug
Meconium stain	28	279.9 185.9–421.4ROR 280.4 · χ² 6,140 / p <1e-300	198.3 EB05 144.0 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=28 · 100% clinician	no trial arm names this drug
Genitalia external ambiguous	31	275.0 186.5–405.4ROR 275.5 · χ² 6,723 / p <1e-300	198.4 EB05 146.4 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=31 · 94% clinician	no trial arm names this drug
Aids encephalopathy	10	262.4 132.8–518.6ROR 262.6 · χ² 1,944 / p <1e-300	154.1 EB05 89.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=10	no trial arm names this drug
Phalangeal hypoplasia	12	256.2 137.7–476.5ROR 256.4 · χ² 2,327 / p <1e-300	159.5 EB05 97.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=12	no trial arm names this drug
Tethered cord syndrome	30	197.8 134.7–290.6ROR 198.2 · χ² 4,909 / p <1e-300	154.5 EB05 113.4 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=30 · 100% clinician	no trial arm names this drug
Blood hiv rna increased	214	173.2 150.3–199.7ROR 175.5 · χ² 32,066 / p <1e-300	150.4 EB05 134.2 · IC025 +6.6 3/3 methods agree	Lab value / disease marker	serious n=207	no trial arm names this drug
Mitochondrial toxicity	96	168.9 136.6–208.9ROR 169.9 · χ² 13,980 / p <1e-300	144.8 EB05 122.1 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=94 · ♀ 0% (drug 35%)	no trial arm names this drug
Congenital pulmonary valve disorder	12	166.1 91.0–303.2ROR 166.2 · χ² 1,597 / p <1e-300	119.5 EB05 72.8 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=12	no trial arm names this drug
Virologic failure	587	156.0 143.4–169.8ROR 161.8 · χ² 80,332 / p <1e-300	138.3 EB05 129.2 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=562 · 93% clinician	no trial arm names this drug
Gastrointestinal malformation	22	148.2 95.3–230.4ROR 148.4 · χ² 2,747 / p <1e-300	119.2 EB05 83.0 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=22 · 100% clinician	no trial arm names this drug
Bone demineralisation	110	147.7 121.3–179.9ROR 148.7 · χ² 14,216 / p <1e-300	129.4 EB05 110.3 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious n=99	no trial arm names this drug
Lipodystrophy acquired	217	144.7 125.8–166.4ROR 146.6 · χ² 27,650 / p <1e-300	128.4 EB05 114.7 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious n=210	no trial arm names this drug
Spine malformation	34	136.8 96.1–194.9ROR 137.1 · χ² 4,013 / p <1e-300	115.6 EB05 86.6 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious n=34	no trial arm names this drug
Brachydactyly	19	136.8 85.2–219.5ROR 136.9 · χ² 2,189 / p <1e-300	110.1 EB05 74.5 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=19	no trial arm names this drug
Trisomy 18	36	132.2 93.8–186.3ROR 132.5 · χ² 4,124 / p <1e-300	112.7 EB05 85.1 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=36 · 100% clinician	no trial arm names this drug
Hiv viraemia	19	128.0 79.9–205.1ROR 128.1 · χ² 2,059 / p <1e-300	104.4 EB05 70.6 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=17	no trial arm names this drug
Bacterial vulvovaginitis	26	127.9 85.5–191.4ROR 128.1 · χ² 2,858 / p <1e-300	107.3 EB05 76.9 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=26 · ♀ 100% (drug 35%)	no trial arm names this drug
Plagiocephaly	44	122.9 90.2–167.4ROR 123.2 · χ² 4,736 / p <1e-300	107.0 EB05 83.0 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=44	no trial arm names this drug
Neonatal respiratory arrest	13	122.2 69.2–215.9ROR 122.3 · χ² 1,316 / p 2e-288	96.2 EB05 59.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Viral mutation identified	308	115.6 103.0–129.8ROR 117.8 · χ² 31,951 / p <1e-300	105.3 EB05 95.8 · IC025 +6.3 3/3 methods agree	Not in label — unassessed	serious n=307 · 96% clinician	no trial arm names this drug
Exomphalos	44	112.9 82.9–153.6ROR 113.2 · χ² 4,376 / p <1e-300	99.3 EB05 77.0 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious n=44	no trial arm names this drug
Viral load decreased	12	112.8 62.5–203.6ROR 112.9 · χ² 1,120 / p 8e-246	89.3 EB05 54.5 · IC025 +3.4 3/3 methods agree	Lab value / disease marker	–	no trial arm names this drug
Anogenital dysplasia	12	110.3 61.2–199.0ROR 110.4 · χ² 1,097 / p 8e-241	87.8 EB05 53.5 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious n=12	no trial arm names this drug
Congenital mitral valve incompetence	11	108.2 58.5–200.3ROR 108.3 · χ² 980 / p 2e-215	85.4 EB05 50.9 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Raltegravir only as a background or rescue medication (NCT00811954, NCT00955968); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Drug interaction	1,211	9.8 9.3–10.4ROR 10.5 · χ² 9,580 / p <1e-300	9.7 EB05 9.3 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 7.4	no trial arm names this drug
Foetal exposure during pregnancy	1,078	17.2 16.2–18.2ROR 18.3 · χ² 16,239 / p <1e-300	16.9 EB05 16.1 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 11.4	no trial arm names this drug
Depression	1,017	5.7 5.4–6.1ROR 6.0 · χ² 3,968 / p <1e-300	5.7 EB05 5.4 · IC025 +2.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.3 · ♀ 13% (drug 35%)	no trial arm names this drug
Anxiety	966	4.3 4.1–4.6ROR 4.5 · χ² 2,502 / p <1e-300	4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.1	no trial arm names this drug
Pain	917	1.9 1.8–2.0ROR 2.0 · χ² 405 / p 2e-90	1.9 EB05 1.8 · IC025 +0.8	Labeled adverse reaction exact term	serious PRR 1.9	no trial arm names this drug
Emotional distress	789	8.3 7.8–8.9ROR 8.7 · χ² 5,088 / p <1e-300	8.3 EB05 7.8 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.3 · 100% consumer	no trial arm names this drug
Maternal exposure during pregnancy	742	10.8 10.1–11.6ROR 11.3 · χ² 6,582 / p <1e-300	10.7 EB05 10.1 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 5.5 · ♀ 98% (drug 35%)	no trial arm names this drug
Exposure during pregnancy	742	15.4 14.4–16.5ROR 16.1 · χ² 9,897 / p <1e-300	15.2 EB05 14.3 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 8.2 · ♀ 99% (drug 35%)	no trial arm names this drug
Anhedonia	708	35.1 32.6–37.7ROR 36.6 · χ² 22,792 / p <1e-300	34.1 EB05 32.1 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 25.1 · 100% consumer	no trial arm names this drug
Virologic failure	587	156.0 143.4–169.8ROR 161.8 · χ² 80,332 / p <1e-300	138.3 EB05 129.2 · IC025 +6.8 3/3 methods agree	Not in label — unassessed	serious n=562 · 93% clinician	no trial arm names this drug
Renal failure (kidney failure)	558	5.3 4.9–5.8ROR 5.5 · χ² 1,972 / p <1e-300	5.3 EB05 4.9 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.7	no trial arm names this drug
Chronic kidney disease	547	9.2 8.4–10.0ROR 9.5 · χ² 3,962 / p <1e-300	9.1 EB05 8.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	no trial arm names this drug
Fatigue (tiredness)	530	0.9 0.8–0.9ROR 0.9 · χ² 10 / p 7e-4	0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 0.9	no trial arm names this drug
Diarrhoea (diarrhea)	526	1.0 1.0–1.1ROR 1.0 · χ² 1 / p 0.160	1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC	Labeled adverse reaction exact term	serious PRR 1.1	no trial arm names this drug
Off label use (used outside approved label)	481	0.7 0.6–0.8ROR 0.7 · χ² 60 / p 4e-15	0.7 EB05 0.7 · IC025 -0.6 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 0.7	no trial arm names this drug

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Cloacal exstrophy — n=32, PRR 1,492.9
Ultrasound antenatal screen — n=50, PRR 1,431.4
Progressive external ophthalmoplegia — n=68, PRR 1,404.1
Bladder agenesis — n=33, PRR 1,013.8
Gastrointestinal disorder congenital — n=32, PRR 552.2
Caudal regression syndrome — n=41, PRR 449.1
Ectopic kidney — n=23, PRR 419.9
Hemivertebra — n=38, PRR 365.4
Csf hiv escape syndrome — n=30, PRR 349.9
Congenital genital malformation — n=31, PRR 302.7

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Raltegravir?

In FDA FAERS, the most frequently co-reported reaction terms for Raltegravir are depression, anxiety, pain, emotional distress, anhedonia, virologic failure. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Raltegravir have an FDA boxed warning?

No. The FDA label retrieved for Raltegravir has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Raltegravir causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID ccc6f2f9-696f-4ef9-bb4c-e0198d957b0b, effective 20241001; matched on openfda.generic_name.exact:"RALTEGRAVIR")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 1,084 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath
ClinicalTrials.gov API v2 (query RALTEGRAVIR, results-bearing studies sorted by enrollment)

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.